Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00276718
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2006-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'C562841', 'term': 'Ovarian Germ Cell Cancer'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'D013724', 'term': 'Teratoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1989-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-02', 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2006-01-12', 'studyFirstSubmitQcDate': '2006-01-12', 'lastUpdatePostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-13', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['childhood malignant ovarian germ cell tumor', 'childhood malignant testicular germ cell tumor', 'childhood central nervous system germ cell tumor', 'childhood extragonadal germ cell tumor', 'childhood teratoma'], 'conditions': ['Brain and Central Nervous System Tumors', 'Childhood Germ Cell Tumor', 'Extragonadal Germ Cell Tumor', 'Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as etoposide, carboplatin, and bleomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain.\n\nPURPOSE: This clinical trial is studying how well giving etoposide, carboplatin, and bleomycin works in treating young patients undergoing surgery for malignant germ cell tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the toxic effects of etoposide, carboplatin, and bleomycin in young patients with malignant germ cell tumors.\n\nOUTLINE: Patients are assigned to one of two treatment arms based on their tumor type (testicular vs ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic).\n\n* Group 1 (testicular tumors): Patients undergo radical orchiectomy. Patients with stage I tumors and alpha-fetoprotein (AFP) decreasing at the expected rate receive no further treatment unless there is a subsequent rise in the AFP or a clinical recurrence. Patients with stage II-IV tumors receive etoposide IV over 1 hour on days 1-3, carboplatin IV over 1 hour on day 2, and bleomycin IV over 15 minutes on day 3. Treatment repeats every 21- 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Residual teratoma may be removed, if indicated, after completion of chemotherapy.\n* Group 2 (ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic germ cell tumors): Patients undergo surgical removal or biopsy of the tumor. Patients then receive etoposide, carboplatin, and bleomycin as above. Patients may then undergo further surgery at the discretion of the principal investigator.\n\nAfter completion of study treatment, patients are followed periodically.\n\nPROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven malignant germ cell tumors at all stages\n\n * Testicular tumors\n\n * Stage I - Confined to testes\n * Stage II - Confined to testes and retroperitoneal/abdominal lymph nodes\n * Stage III - Supradiaphragmatic nodal disease (mediastinal and/or supraclavicular)\n * Stage IV - Extralymphatic spread (liver, lung, bone, brain, skin, etc.)\n * Ovarian, uterine, vaginal, and sacrococcygeal tumors\n\n * Stage I - Confined to ovary/uterus/vagina/pre- and postsacral area\n * Stage II - Spread limited to the pelvis\n * Stage III - Spread limited to the abdomen (excluding liver)\n * Stage IV - Spread to liver or beyond the abdominal cavity\n * Abdominal, retroperitoneal, and thoracic primary tumors\n\n * Stage I - Confined to site of origin and resectable\n * Stage II - Local spread\n * Stage III - Extensive spread confined to one side of the diaphragm (excluding the liver)\n * Stage IV - Tumor spread to the liver, to both sides of the diaphragm, and/or to bones, bone marrow, brain, etc.\n * Intracranial germ cell tumor cases allowed even if an alternative protocol is being followed\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy'}, 'identificationModule': {'nctId': 'NCT00276718', 'briefTitle': 'Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Germ Cell Tumour Study II', 'orgStudyIdInfo': {'id': 'CDR0000454749'}, 'secondaryIdInfos': [{'id': 'CCLG-GC-1989-01'}, {'id': 'EU-20583'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bleomycin sulfate', 'type': 'BIOLOGICAL'}, {'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'etoposide', 'type': 'DRUG'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12', 'city': 'Dublin', 'country': 'Ireland', 'facility': "Our Lady's Hospital for Sick Children", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS2 8AE', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Institute of Child Health at University of Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'BS2 8BJ', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Bristol Royal Hospital for Children', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "Leeds Cancer Centre at St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'L12 2AP', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': "Royal Liverpool Children's Hospital, Alder Hey", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'E1 1BB', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1N 3JH', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital for Children NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M27 4HA', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': "Central Manchester and Manchester Children's University Hospitals NHS Trust", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Sir James Spence Institute of Child Health', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': "Queen's Medical Centre", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': '0X3 9DU', 'city': 'Oxford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Oxford Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'S10 2TH', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': "Children's Hospital - Sheffield", 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust - Surrey', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'BT12 6BE', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Royal Belfast Hospital for Sick Children', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'AB25 2ZG', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': "Royal Aberdeen Children's Hospital", 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'EH9 1LF', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G3 8SJ', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Childrens Hospital for Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'A. Oakhill, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bristol Royal Hospital for Children'}, {'name': 'Michael Sokal', 'affiliation': 'Nottingham City Hospital'}, {'name': 'P. Gornall, MD', 'affiliation': "Birmingham Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Cancer and Leukaemia Group", 'class': 'OTHER'}}}}